In mifepristone case, the Supreme Court must affirm the FDA’s authority. Medical innovation is at risk

On Wednesday, the Supreme Court announced it will soon weigh in on a case that challenges how the Food and Drug Administration regulates mifepristone, a drug it approved almost 25 years ago that is used to terminate pregnancy.

The case, the Alliance for Hippocratic Medicine v. FDA, is disguised as a dispute over safety. In reality, it’s about whether the courts will go along with overturning, for political reasons, the authority of the FDA as the scientific arbiter of approval of new drugs and restrictions on their distribution.

The Supreme Court must rule in a way that affirms the FDA’s authority.

For nearly a century, federal law has recognized the FDA as the government decision-maker on whether medicines are safe and effective. Allowing judges to intervene in those evaluations is not only inappropriate from a scientific standpoint; it also poses a serious threat to medical innovation.

Several anti-abortion groups brought Alliance for Hippocratic Medicine v. FDA in November 2022, months after the Supreme Court overturned Roe v. Wade. The lawsuit seeks to overturn approval of mifepristone, and subsequent modifications to that approval. It would impact access nationwide. In 2023, U.S. District Court Judge Matthew Kacsmaryk suspended mifepristone approval in response to a separate legal challenge. The Supreme Court put that ruling — along with subsequent decisions by the 5th Circuit Court of Appeals — on hold shortly thereafter.

The 5th Circuit Court of Appeals issued its substantive decision in the case in August, ruling that FDA was wrong to update the approval conditions such that the drug could be prescribed by telemedicine. In other words, it second-guessed the FDA’s scientific expertise on these matters just as Judge Kacsmaryk had.

If left to stand, the opinion would dramatically alter the FDA’s ability to modify drug approvals to keep pace with science — and would effectively open the door for any physician, whether or not they treat patients using the drug in question, to challenge the FDA’s approval. The Supreme Court has now decided to take up the case.

It is deeply troubling that lower courts have seen fit to undermine a settled agency approval on scientific grounds, substituting the courts’ nonexpert judgment for the FDA’s expert analysis. This is especially true for a drug approval that has been established for so many years.

For one, judges lack the scientific knowledge and understanding to determine whether a medicine is safe and effective, including whether and in what form distribution restrictions are needed. At every opportunity, federal lawmakers have entrusted that job to experts at the FDA. And the agency has consistently performed those duties with rigor and dispassion. Consider that, of the new potential medicines entering clinical trials each year (itself a milestone that a minority of drug candidates achieve), a mere 12% earn FDA approval.

Leaving scientific approval decisions to judges would needlessly weaken the long-standing FDA approval framework. And it would do so in a way that allows — and propels — politically motivated plaintiffs to challenge the scientific conclusions of the FDA. This could destabilize the life sciences industry, undermine investment, and ultimately put patients’ health at risk.

The threats to medical innovation are serious. When one considers unsuccessful candidate medicines, each newly approved drug can cost billions of dollars to commercialize. Bringing a new drug to patients can take more than 10 years. One of the only guarantees in the drug-development process is that a medicine that meets the FDA’s strict standards can be made available to any patient who needs it. If a judge is able to pull an FDA-approved medicine from the market based on a spurious lawsuit from any party, the entire enterprise of drug innovation could become financially untenable. Investment in new medicines would drop, slowing medical progress and making lifesaving breakthroughs even rarer.

This would happen at a moment when revolutionary new treatments for everything from cancer to Alzheimer’s are finally within reach.

Whether or not mifepristone — or any other medicine — is safe and effective isn’t a question for the courts. It’s a matter that should be decided only by the qualified regulators and medical professionals at the FDA. Opening up such decisions to legal challenges by nonexperts is as dangerous for the well-being of patients as it is for the future of medical science.

Eva A. Temkin is a partner in King & Spalding’s FDA and Life Sciences Practice. She formerly served as director for policy at the FDA’s Office of Therapeutic Biologics and Biosimilars and associate chief counsel at the FDA’s Office of the Chief Counsel. Grace E. Colón, Ph.D, is the former president and CEO of InCarda Therapeutics, a former venture capital partner, and currently serves on the boards of several public and private biotechnology companies.